Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction

Completed

• Conditions: Vasculogenic Erectile Dysfunction

• Registration Number: NCT02005731
• Lead Sponsor: Initia

Brief Summary

This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

• Good general health
• Vasculogenic ED for at least 6 months
• International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
• Positive response to PDE5-I (able to penetrate on demand, Responders)
• Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
• Stable heterosexual relationship for more than 3 months

Exclusion Criteria

• Psychogenic ED
• Neurological pathology
• Hormonal pathology
• Past radical prostatectomy
• Recovering from cancer during last 5 years
• Any unstable medical, psychiatric, spinal cord injury and penile anatomical - abnormalities
• Clinically significant chronic hematological disease
• Anti-androgens, oral or injectable androgens
• Radiotherapy in pelvic region

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment	1, 3 and 6 months post treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment	1, 3 and 6 months post treatment
Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment	1, 3 and 6 months post treatment

Trial Locations

Locations (4)

Urologickaambulance; 🇨🇿 Brno, Czech Republic

Amber Clinic; 🇱🇹 Klaipėda, Lithuania

Men's Health Clinic, Amstelland Hospital; 🇳🇱 Amsterdam, Netherlands

Urology and Andrology Center, Red Crescent Hospital (RCH); 🇵🇸 Ramallah, Palestinian Territories, Occupied